Phase I/II Clinical Study of Pralatrexate in Japanese Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

NCT02013362 | Completed Phase 1 DMC

• 1 other identifier: PDX-JP1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

Phase I portion: To evaluate the safety and tolerability of pralatrexate with concurrent vitamin B12 and folic acid supplementation in Japanese patients with relapsed or refractory PTCL and to determine the recommended dosage. Also, to evaluate pharmacokinetics. Phase II portion: To evaluate the efficacy, safety, and pharmacokinetics of the recommended dosage regimen determined in the phase I portion. The primary efficacy endpoint shall be objective response rate (ORR).

Conditions

Peripheral T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) per independent central review committee

  The ORR is defined as the proportion of patients with complete response (CR) and partial response (PR). Response will be determined according to International Workshop Criteria (IWC). Assessments will be done at week 7 (end of Cycle 1), subsequently every 14 weeks (end of odd-numbered cycle).

  From screening period until first documented disease progression or treatment discontinuation from any cause, whichever came first. Duration is approximately 3 years.

Study Arms (1)

Pralatrexate injection

EXPERIMENTAL

Dietary Supplement: Vitamin B12, Folic Acid

Drug: Pralatrexate injection; Dietary Supplement: Vitamin B12; Dietary Supplement: Folic Acid

Interventions

Pralatrexate injection DRUG

Pralatrexate injection

Vitamin B12 DIETARY_SUPPLEMENT

Pralatrexate injection

Folic Acid DIETARY_SUPPLEMENT

Pralatrexate injection

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Japanese patients at least 20 years of age.
• Patients histologically diagnosed with peripheral T-cell lymphoma by pathological diagnosis of biopsied lesion.
• Relapsed or refractory patients with a treatment history of at least one regimen.
• Patients with an enlarged lymph node or extranodal mass lesion clearly measurable in two perpendicular directions and greater than 1.5 cm in maximum diameter on computed tomography performed.
• Patients expected to survive for at least 3 months.
• ECOG PS 0-2.
• Patients with adequate hemopoietic efficacy, liver and kidney function.
• Patients from whom written consent has been obtained prior to study initiation.

You may not qualify if:

• Patients who received a chemotherapy agent or a high dose of a systemic adrenocorticosteroid within 21 days prior to initial administration of the study drug.
• Patients who received radiation therapy, phototherapy, or electron beam therapy within 21 days prior to initial administration of the study drug.
• Patients who received another study drug within 28 days prior to initial administration of the study drug.
• Patients who received antibody therapy within 100 days prior to initial administration of the study drug.
• Patients with a history of allogeneic hematopoietic stem cell transplantation. Or patients with a history of autologous hematopoietic stem cell transplantation within 100 days prior to initial administration of the study drug.
• Patients with cerebral metastasis or central nervous system lesion or a past history.
• Patients with active multiple primary cancer. Or patients with a history of a malignant neoplasm other than peripheral T-cell lymphoma within the past 5 years.
• Patients with severe cardiovascular disease.
• Patients positive for HBs antigen, HCV antibody or HIV antibody on immunological investigation. Or patients positive for either HBc antibody or HBs antibody, and showing DNA more than sensitivity in HBV-DNA assay.
• Patients positive for CMV antigen on immunological investigation.
• Patients with infectious disease requiring treatment consisting of intravenous administration of antibacterial agent, fungicide, or antiviral drug.
• Patients with interstitial pneumonia or pulmonary fibrosis, or patients judged to have insufficient pulmonary function.

Sponsors & Collaborators

• Mundipharma K.K.: lead

Study Sites (3)

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, 460-0001, Japan

Location

National Cancer Center Hospital

Chūō, Tokyo, 104-0045, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Related Publications (1)

• Maruyama D, Nagai H, Maeda Y, Nakane T, Shimoyama T, Nakazato T, Sakai R, Ishikawa T, Izutsu K, Ueda R, Tobinai K. Phase I/II study of pralatrexate in Japanese patients with relapsed or refractory peripheral T-cell lymphoma. Cancer Sci. 2017 Oct;108(10):2061-2068. doi: 10.1111/cas.13340. Epub 2017 Sep 4.

  PMID: 28771889 DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

10-propargyl-10-deazaaminopterin; Vitamin B 12; Folic Acid

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring

Study Officials

• Kensei Tobinai, MD,PhD

  National Cancer Center Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 17, 2013
• Study Start: March 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: September 1, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-11

Locations

JP (3)